BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXION HUMERAL NAILING SYSTEM CONNECTION TUBE

    MDR report key: 6857300 · Received September 12, 2017

    Report

    Report Number
    9615128-2017-00039
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    April 16, 2015
    Report Date
    May 22, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K013449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE ITEM DETECTED THAT THE DISTAL END OF THE CONNECTION TUBE WAS BROKEN. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICE DID NOT REVEAL A DEVIATION THAT MAY HAVE CONTRIBUTED TO THE REPORTED CASE. THIS REPORT IS SUBMITTED FOLLOWING AN FDA INSPECTION AT THE MANUFACTURER FACILITY NOTE:THIS PRODUCT IS NO LONGER MARKETED IN THE USA

    Description of Event or Problem · 1

    DURING OF A FIXION NAIL EXTRACTION IN (B)(6) THE FIXION HUMERAL CONNECTION TUBE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637095 FIXION HUMERAL NAILING SYSTEM CONNECTION TUBE INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. IL01534

    Patients

    Seq Age Sex Outcome Treatment
    1